18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BRILLIANT Crios
FDA 510(k)
FDA Class 2
·Dental
Lateral Patient Positioning System
FDA UDI
ALPHATEC SPINE, INC.·00190376484235·Arm Board
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668101025·JAEGER LID PLATE PLASTIC
Life Instruments
FDA UDI
Life Instrument Corporation·M930718150000·Down Pushing Curete #0
Origin Hip Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215051518·
Origin
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215001438·
Paxeon Origin
FDA UDI
PAXEON RECONSTRUCTION LLC·08177570200580·Origin Stem, Standard Offset Size 15
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161111815000·Origin Hip Stem, Standard Offset Collarless, Ce...
Echotip
FDA UDI
COOK INCORPORATED·00827002163485·Echotip Disposable Mennuti Sampling Needle Set
OPTIO-C ANTERIOR CERVICAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 11, 2025
STRATUS Stem
FDA UDI
AMPLITUDE SAS·03701089521208·
CALLCORD,18",1500,MECH.,E-Z CARE WIRING
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828160254·CALLCORD,18",1500,MECH.,E-Z CARE WIRING
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 21, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 7, 2011
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014